HealthyNCT05897411
Deconditioning of Acquired Food Aversion
A study testing Unmasking previous conditioning procedure and No unmasking of previous conditioning in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Background. Aversive conditioning impairs the rewarding value of a comfort meal. Our aim is to demonstrate the potential effect of deconditioning to reverse aversive conditioning and restore the hedonic postprandial response. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Unmasking previous conditioning procedure and No unmasking of previous conditioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- non-obese
Who cannot join
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
- alcohol abuse
- psychological disorders
- eating disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors That Determine the Responses to Meal Ingestion: Deconditioning of Acquired Food Aversion
Background. Aversive conditioning impairs the rewarding value of a comfort meal.
Our aim is to demonstrate the potential effect of deconditioning to reverse aversive conditioning and restore the hedonic postprandial response.
Read more
Methods: A sham-controlled, randomised, parallel, single-blind study will be performed on 12 healthy women (6 per group). The rewarding value of a comfort meal will be measured at initial exposure, after aversive conditioning (masked administration of the same meal with a high-fat content) and after a deconditioning intervention (unmasking the aversive conditioning paradigm in the deconditioning group vs sham intervention in the control group). Digestive well-being (primary outcome) will be measured every 10 min before and 60 min after ingestion using graded scales. The effect of deconditioning (change from aversive conditioning to deconditioning) will be compared to sham deconditioning in the control group.
Expected results: The comfort meal at first exposure will induce a pleasant postprandial experience, which will be impaired by aversive conditioning; this effect will be reverted by deconditioning and the hedonic value of the comfort meal will be restored.
- Conditions
- Healthy
- Being tested
- Unmasking previous conditioning procedure, No unmasking of previous conditioning
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, deconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unmasking previous conditioning procedureBehavioural
An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will be provided.
No unmasking of previous conditioningBehavioural
An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will not be provided.
| Study group | Role | What they receive |
|---|---|---|
| Deconditioning | Experimental | Not described Receives: Behavioral: Unmasking previous conditioning procedure |
| Sham deconditioning | Sham comparator | Not described Receives: Behavioral: No unmasking of previous conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in postprandial digestive well-being before and after deconditioning
Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a probe meal before and after deconditioning.
Measured: 120 minutes
Difference in postprandial fullness sensation before and after conditioning
Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning.
Measured: 120 minutes
Change in postprandial mood before and after conditioning
Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a probe meal before and after conditioning.
Measured: 120 minutes
Change in postprandial hunger/satiety before and after conditioning
Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a probe meal before and after conditioning.
Measured: 120 minutes
Change in postprandial discomfort before and after conditioning
Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start10 Jan 2023
- Primary completion15 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897411
- Sponsor's protocol ID
- PR(AG)338/2016N
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nieto A, Livovsky DM, Azpiroz F. Conditioning by a Previous Experience Impairs the Rewarding Value of a Comfort Meal. Nutrients. 2023 May 9;15(10):2247. doi: 10.3390/nu15102247.
PubMed 37242129Nieto A, Livovsky DM, Azpiroz F. Reversal of Conditioned Food Aversion Using a Cognitive Intervention: A Sham-Controlled, Randomized, Parallel Study. Nutrients. 2023 Nov 29;15(23):4962. doi: 10.3390/nu15234962.
PubMed 38068820
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Determine the Responses to Meal Ingestion: Deconditioning of Acquired Food Aversion
- ClinicalTrials.gov ID
- NCT05897411
- Acronym / sponsor ID
- PR(AG)338/2016N
- Conditions
- Healthy
- Keywords
- meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, deconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background. Aversive conditioning impairs the rewarding value of a comfort meal.
Our aim is to demonstrate the potential effect of deconditioning to reverse aversive conditioning and restore the hedonic postprandial response.
Methods: A sham-controlled, randomised, parallel, single-blind study will be performed on 12 healthy women (6 per group). The rewarding value of a comfort meal will be measured at initial exposure, after aversive conditioning (masked administration of the same meal with a high-fat content) and after a deconditioning intervention (unmasking the aversive conditioning paradigm in the deconditioning group vs sham intervention in the control group). Digestive well-being (primary outcome) will be measured every 10 min before and 60 min after ingestion using graded scales. The effect of deconditioning (change from aversive conditioning to deconditioning) will be compared to sham deconditioning in the control group.
Expected results: The comfort meal at first exposure will induce a pleasant postprandial experience, which will be impaired by aversive conditioning; this effect will be reverted by deconditioning and the hedonic value of the comfort meal will be restored.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deconditioning | Experimental | Behavioral: Unmasking previous conditioning procedure |
| Sham deconditioning | Sham comparator | Behavioral: No unmasking of previous conditioning |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -
- non-obese
Key exclusion criteria (8 listed)
- history of gastrointestinal symptoms
- prior obesity
- use of medications
- history of anosmia and ageusia
- current dieting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unmasking previous conditioning procedureAn explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will be provided. | Behavioural | Deconditioning |
| No unmasking of previous conditioningAn explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will not be provided. | Behavioural | Sham deconditioning |
Primary outcome
Difference in postprandial digestive well-being before and after deconditioning
Time frame: 120 minutes
Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a probe meal before and after deconditioning.
Difference in postprandial fullness sensation before and after conditioning
Time frame: 120 minutes
Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning.
Change in postprandial mood before and after conditioning
Time frame: 120 minutes
Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a probe meal before and after conditioning.
Change in postprandial hunger/satiety before and after conditioning
Time frame: 120 minutes
Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a probe meal before and after conditioning.
Change in postprandial discomfort before and after conditioning
Time frame: 120 minutes
Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a probe meal before and after conditioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 37242129Nieto A, Livovsky DM, Azpiroz F. Conditioning by a Previous Experience Impairs the Rewarding Value of a Comfort Meal. Nutrients. 2023 May 9;15(10):2247. doi: 10.3390/nu15102247.
- Derived from this study: PubMed 38068820Nieto A, Livovsky DM, Azpiroz F. Reversal of Conditioned Food Aversion Using a Cognitive Intervention: A Sham-Controlled, Randomized, Parallel Study. Nutrients. 2023 Nov 29;15(23):4962. doi: 10.3390/nu15234962.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unmasking previous conditioning procedure and No unmasking of previous conditioning in people with Healthy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in postprandial digestive well-being before and after deconditioning (time frame: 120 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.